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Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014

NCT00614614 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1558

Last updated 2018-09-21

Study results available
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Summary

The purpose of the study is to characterize the immunogenicity \& safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and open-label for the booster phase.

Conditions

  • Infections, Meningococcal

Interventions

BIOLOGICAL

GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix)

One dose in the booster phase as intramuscular injection

BIOLOGICAL

GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix)

Three doses in the priming phase and, for Menhibrix 2 Group, one dose in the booster phase as intramuscular injection

BIOLOGICAL

Infanrix®

One dose as intramuscular injection

BIOLOGICAL

ActHIB®

Three doses in the priming phase as intramuscular injection

BIOLOGICAL

Pediarix®

Three doses in the priming phase as intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-13
Primary Completion
2009-07-31
Completion
2009-09-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00614614 on ClinicalTrials.gov